Recall Z-1039-2019— Shimadzu Medical Systems Usa Com

Name: FDA recall Z-1039-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-14

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems Usa Com, initiated 2019-01-14, terminated 2023-04-13. It names one FDA 510(k) clearance: K080701. Product: SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).. Reason: In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast..

Recalling firm: Shimadzu Medical Systems Usa Com
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Terminated: 2023-04-13
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080701 — SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONShimadzu Corp.·cleared 2008-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

Reason for recall

In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.

Data sourced from openFDA. This site is unofficial and independent of the FDA.